AtelectasisATELHONCT05384795
Perioperative Atelectasis in Orthopaedic Surgery: a Prospective Study
An observational study of Atelectasis, run by Eric Albrecht at 1 site in Switzerland.
Trial summary
This study aims at comparing a perioperative pulmonary atelectasis score, measured by pulmonary ultrasound, in patients operated undergoing orthopedic surgery under general anesthesia, spinal anesthesia or peripheral nerve block. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atelectasis
- What is being tested?
- Lung ultrasound
- How many people
- 141 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 May 2022to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be patients scheduled for elective surgery at the Orthopedic Hospital from CHUV.
Who may be able to join
- Patients over the age of 18;
- Patients scheduled for an elective operation at the Orthopedic Hospital of CHUV;
- Signature of the study consent
Who cannot join
- Thoracic deformities preventing the performance of pulmonary ultrasound (dressings, drains, fractures, etc.);
- Refusal to participate;
- Patient does not speak French.
- Inability to discern
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1005
About this study
Official title: Perioperative Atelectasis in Patients Undergoing Orthopaedic Surgery: Prospective Cohort Study
This study aims at comparing a perioperative pulmonary atelectasis score, measured by pulmonary ultrasound, in patients operated undergoing orthopedic surgery under general anesthesia, spinal anesthesia or peripheral nerve block. The association between the atelectasis score and previously identified risk factors will be studied.
Read the detailed description
Atelectasis is one of the most common pulmonary complications in the perioperative period, occurring in 85% to 90% of patients under general anesthesia. It can be responsible for hypoxemia and be associated with postoperative pulmonary complications such as pneumonia. The consequences are a prolongation of the hospital stay and an increase in mortality.
The appearance of perioperative atelectasis is mainly secondary to the induction of general anesthesia with an incidence up to 90%. The different causes are, for example, the administration of muscle relaxants, mechanical ventilation and the position of the patient.
In orthopedic surgery, many procedures are performed under spinal anesthesia or under peripheral nerve block. At present, there are no studies measuring the incidence of atelectasis in patients operated under these two techniques of locoregional anesthesia, with the exception of parturients undergoing cesarean section.
This study aims at comparing a perioperative pulmonary atelectasis score, measured by pulmonary ultrasound, in patients operated undergoing orthopedic surgery under general anesthesia, spinal anesthesia or peripheral nerve block. The association between the atelectasis score and previously identified risk factors will be studied.
- Conditions
- Atelectasis
- Being tested
- Lung ultrasound
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung ultrasoundOther
Lung atelectasis score
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia | Not described Receives: Other: Lung ultrasound | |
| Spinal anesthesia | Not described Receives: Other: Lung ultrasound | |
| Peripheral nerve block | Not described Receives: Other: Lung ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung atelectasis score
Atelectasis score based on validated ultrasound quantification (comparing different anesthesia techniques)
Measured: immediately after the surgery
Secondary outcomes (1)
Lung atelectasis score
Atelectasis score
Measured: Four timepoints: at baseline, immediatly before surgery (after anesthesia induction), immediately after the surgery, and at the recovery room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start16 May 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtelectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eric Albrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eric Albrecht, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384795
- Sponsor's protocol ID
- CER-VD 2022-00712
- Acronym
- ATELHO
- Status last verified
- Apr 2023
- First submitted
- 13 May 2022
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Fully anonymised IPD will be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Atelectasis in Patients Undergoing Orthopaedic Surgery: Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05384795
- Acronym / sponsor ID
- ATELHO / CER-VD 2022-00712
- Conditions
- Atelectasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Eric AlbrechtUniversity, hospital or other
- Study start
- 16 May 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 20 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims at comparing a perioperative pulmonary atelectasis score, measured by pulmonary ultrasound, in patients operated undergoing orthopedic surgery under general anesthesia, spinal anesthesia or peripheral nerve block. The association between the atelectasis score and previously identified risk factors will be studied.
Detailed description
Atelectasis is one of the most common pulmonary complications in the perioperative period, occurring in 85% to 90% of patients under general anesthesia. It can be responsible for hypoxemia and be associated with postoperative pulmonary complications such as pneumonia. The consequences are a prolongation of the hospital stay and an increase in mortality.
The appearance of perioperative atelectasis is mainly secondary to the induction of general anesthesia with an incidence up to 90%. The different causes are, for example, the administration of muscle relaxants, mechanical ventilation and the position of the patient.
In orthopedic surgery, many procedures are performed under spinal anesthesia or under peripheral nerve block. At present, there are no studies measuring the incidence of atelectasis in patients operated under these two techniques of locoregional anesthesia, with the exception of parturients undergoing cesarean section.
This study aims at comparing a perioperative pulmonary atelectasis score, measured by pulmonary ultrasound, in patients operated undergoing orthopedic surgery under general anesthesia, spinal anesthesia or peripheral nerve block. The association between the atelectasis score and previously identified risk factors will be studied.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| General anesthesia | – | Other: Lung ultrasound |
| Spinal anesthesia | – | Other: Lung ultrasound |
| Peripheral nerve block | – | Other: Lung ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be patients scheduled for elective surgery at the Orthopedic Hospital from CHUV.
Key inclusion criteria (3 listed)
- Patients over the age of 18;
- Patients scheduled for an elective operation at the Orthopedic Hospital of CHUV;
- Signature of the study consent
Key exclusion criteria (4 listed)
- Thoracic deformities preventing the performance of pulmonary ultrasound (dressings, drains, fractures, etc.);
- Refusal to participate;
- Patient does not speak French.
- Inability to discern
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung ultrasoundLung atelectasis score | Other | General anesthesia, Peripheral nerve block, Spinal anesthesia |
Primary outcome
Lung atelectasis score
Time frame: immediately after the surgery
Atelectasis score based on validated ultrasound quantification (comparing different anesthesia techniques)
1 secondary outcome
Lung atelectasis score
Time frame: Four timepoints: at baseline, immediatly before surgery (after anesthesia induction), immediately after the surgery, and at the recovery room
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Individual participant dataSharing planned: Undecided. Fully anonymised IPD will be shared upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atelectasis, run by Eric Albrecht at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung atelectasis score (time frame: immediately after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2023.